CN102636618A - Method for quality inspection of magnesium sulfate wet dressing sheet - Google Patents
Method for quality inspection of magnesium sulfate wet dressing sheet Download PDFInfo
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- CN102636618A CN102636618A CN2012101425527A CN201210142552A CN102636618A CN 102636618 A CN102636618 A CN 102636618A CN 2012101425527 A CN2012101425527 A CN 2012101425527A CN 201210142552 A CN201210142552 A CN 201210142552A CN 102636618 A CN102636618 A CN 102636618A
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- magnesium sulfate
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- dressing sheet
- osmotic pressure
- adlerika
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Abstract
The invention discloses a method for quality inspection of a magnesium sulfate wet dressing sheet, comprising identification, content determination, pH determination, determination of microbial indicators, osmolarity determination and other steps. The amount of a magnesium sulfate solution is that each square centimeter of magnesium sulfate wet dressing sheet contains 0.07g of the magnesium sulfate solution; a test solution is prepared by a sample washing method to ensure the content of magnesium sulfate in the wet dressing sheet; the content of magnesium sulfate in the magnesium sulfate solution is 25% to 50%; the magnesium sulfate wet dressing sheet achieves the purpose of eliminating and relieving edema by absorbing moisture in the subcutaneous tissue of an affected part through the hypertonic action of high-concentration magnesium sulfate solution. The osmolarity set by the invention is 1.9-2.9 Osmol/kg. The method for quality inspection disclosed by the invention can be used for both qualitative detection and quantitative detection, and represents the pharmacological activity of the magnesium sulfate wet dressing sheet. The method not only can effectively characterize the intrinsic quality of the magnesium sulfate wet dressing sheet, and is more suitable for effective control of the product quality in the production process.
Description
Technical field
The invention belongs to field of medical technology, relate to the quality control standard of magnesium sulfate dressing sheet, the quality determining method of a kind of magnesium sulfate dressing sheet of saying so more specifically.
Background technology
For many years, in venous transfusion,, cause the incident that swelling pain appears in local subcutaneous tissue and happen occasionally because negligent supervision causes non-aggressive, corrosive medicine or solution to get into surrounding tissue causes and ooze out and exosmose.Have in recent years, malignant tumor patient uses chemotherapeutic often to cause shallow table phlebitis in various degree, brings very big misery to patient, and influences carrying out smoothly of chemotherapy again.Occur the above-mentioned symptom doctor adopt nurse and methods of treatment; Generally be to give the patient with the Adlerika and the gauze of the variable concentrations for preparing; Instrucion is folding with gauze, spreads on the affected part to alleviate the degree of swelling after soaking with Adlerika, reaches anti-inflammatory and goes the purpose that swells.But because the difference on the individual operations can not guarantee Adlerika, gauze and utensil are operated under the environment of cleaning sterile in use, be easy to cause bacteria attack, infect in the affected part of patient's swelling as a result, has more increased patient's misery.The patient carries Adlerika and gauze voluntarily in addition, and needs of patients notes on gauze, adding at any time medicine during use, keeps local moist and enough drug concentrations, has brought very big inconvenience to the patient.Clinical use preparation also be rule of thumb confirm concentration as: 25% solution of preparation 100mL is with 1/4th magnesium sulphate, 25 g; 33% usefulness, 1/3rd magnesium sulphate 33g of preparation 100mL; 50% usefulness, 1/2nd magnesium sulphate 50g of preparation 100mL, just clinical for ease use convenient configuration does not have the technology quality index and the method for inspection.If the industrialization of magnesium sulfate dressing sheet production standard just should be formulated the quality of the method for quality inspection in order to the control product.
The present invention is that the moistening degree in the magnesium sulfate dressing sheet is controlled in 0.07g ± 0.02 with every square centimeter of Adlerika amount of extruding; Calculate MgSO by the product indicia amount
47H
2Magnesium sulphate content should be 25-50% ± 7 and controls magnesium sulphate content in the O Adlerika; Should be 1.9-2.9 ± 0.7 Osmol/kg with osmotic pressure molar density mensuration, control product osmotic pressure molar density.Quality determining method of the present invention not only can carry out qualitative detection, can also carry out detection by quantitative, has represented the pharmacologically active of magnesium sulfate dressing sheet, can not only characterize its inherent quality effectively, is more suitable for effective control of product quality in production run.
Summary of the invention
The objective of the invention is to set up a kind of quality determining method of magnesium sulfate dressing sheet, can effectively control the quality of magnesium sulfate dressing sheet through this assay method.
For realizing above-mentioned purpose, the present invention provides following technology contents:
A kind of quality determining method of magnesium sulfate dressing sheet comprises: the step that discriminating, assay, potential of hydrogen mensuration, microbiological indicator mensuration, assay, osmotic pressure molar density are measured is characterized in that:
(1) assay is undertaken by following step:
1) get 1 of test sample, measure its area, with the magnesium sulfate dressing sheet syringe of packing into, the extruding of push injection device, answering the sulfur acid magnesium solution in every square centimeter of magnesium sulfate dressing sheet is 0.07g ± 0.02;
2) the magnesium sulphate content of Adlerika should be 25-50% ± 7 in the magnesium sulfate dressing sheet; Its method:
Get the magnesium sulfate dressing sheet as test sample, get the Adlerika of extruding and try solution, get 1mL and supply examination solution, put in the 25mL measuring bottle as supplying; Test sample 10cm with the Adlerika of extruding
2, put in the beaker, add water 5ml, soaked 15 minutes and stirring constantly, soak solution is transferred in the 25ml measuring bottle, water 5ml washing is 3 times respectively, merges cleansing solution to the 25ml measuring bottle, and thin up shakes up to scale, is dilution; Precision is measured dilution 10mL ammonification-ammonium chloride buffer (pH10.0) 10mL, chromium black T indicator a little, with Calcium Disodium Versenate vs (0.05mol/L) titration, change pure blue into by aubergine to solution, promptly get; Every 1mL Calcium Disodium Versenate vs (0.05mol/L) is equivalent to the MgSO of 12.32mg
47H
2O is through calculating the requirement that should meet the product indicia amount.
(2) osmotic pressure molar density is measured and is undertaken by following step:
1. get that to extrude Adlerika an amount of as supplying examination solution, getting newly boils in right amount puts cold water and rectifies an instrument zero point, selects two kinds of standard solution to rectify an instrument then, measures the osmotic pressure molar density of need testing solution again, should be 1.9-2.9 ± 0.7 Osmol/kg;
2. the preparation of osmotic pressure molar density standard solution:
Get benchmark sodium chloride reagent,, put to put in the silica gel drier and be chilled to room temperature in 500～600 ℃ of dryings 40～50 minutes; Take by weighing in right amount by " osmotic pressure molar density determinator is proofreaied and correct and used the standard solution table " institute's column data precision, be dissolved in the 100ml water, shake up, promptly get;
3. osmotic pressure molar density determinator is proofreaied and correct and is used the standard solution table
| Milli osmotic pressure molar density (mOsmol/kg) | The weight (g) of sodium chloride in every 100g water |
| 1000 | 3.201 |
| 2000 | 6.420 |
| 3000 | 9.638 |
The more detailed detection method of the present invention is following:
1 supplies producing of examination solution, gets the magnesium sulfate dressing sheet as test sample, and with the magnesium sulfate dressing sheet syringe of packing into, the extruding of push injection device is got the Adlerika extruded as supplying examination solution;
2 differentiate
Try solution 2.1 get the 50mL Adlerika of extruding as confession by 1.
2.2 sulfate: get and supply examination solution, drip the barium chloride test solution, promptly generate white precipitate, separate, be deposited in hydrochloric acid or the nitric acid and all do not dissolve.
2.3 magnesium salts: get and supply examination solution, hydro-oxidation sodium test solution promptly generates white precipitate, separates, and deposition is divided into two parts, adds excessive sodium hydroxide test solution in the portion, precipitates insoluble; Another part adds iodine test solution, and deposition changes into rufous.
Answer the quantitative determination of sulfur acid magnesium solution in 3 every square centimeter of magnesium sulfate dressing sheets
3.1 by answering sulfur acid magnesium solution amount in every square centimeter of magnesium sulfate dressing sheet of product indicia amount calculating, answering the sulfur acid magnesium solution in every square centimeter of magnesium sulfate dressing sheet is 0.07g ± 0.02, as: area is 6 * 9cm=54 cm
2The magnesium sulfate dressing sheet calculate the Adlerika amount and should be 2.70 g-4.86 g;
3.2 by 1 supply examination solution preparation method, squeeze the Adlerika of getting in 1 of the test sample, get the Adlerika of extruding and carry out weighing with balance, calculating by 3.1 should be up to specification.
Magnesium sulphate assay in the 4 magnesium sulfate dressing sheets in the Adlerika, MgSO
47H
2O content should be 25-50% ± 7;
4.1 get the magnesium sulfate dressing sheet as test sample, get the Adlerika of extruding and try solution as supplying, get 1mL and supply examination solution, put in the 25mL measuring bottle; Test sample 10cm with the Adlerika of extruding
2, put in the beaker, add water 5ml, soaked 15 minutes and stirring constantly, soak solution is transferred in the 25ml measuring bottle, water 5ml washing is 3 times respectively, merges cleansing solution to the 25ml measuring bottle, and thin up shakes up to scale, is dilution; Precision is measured dilution 10mL ammonification-ammonium chloride buffer (pH10.0) 10mL, chromium black T indicator a little, with Calcium Disodium Versenate vs (0.05mol/L) titration, change pure blue into by aubergine to solution, promptly get; Every 1mL Calcium Disodium Versenate vs (0.05mol/L) is equivalent to the MgSO of 12.32mg
47H
2O is through calculating the requirement that should meet the product indicia amount.
5 osmotic pressure molar densities are measured and should be 1.9-2.9 Osmol/kg
± 0.7
Get the 50mL Adlerika of extruding by 1 and try solution as confession.Get 8-10mL as supplying examination solution
5.1 getting 8-10mL newly boils and puts cold water and rectify an instrument zero point;
5.2 select two kinds of standard solution to rectify an instrument according to the requirement of product indicia amount then,
5.4 rectify an instrument respectively or rectify an instrument respectively with 2000 milli osmotic pressure molar densities and 3000 milli osmotic pressure molar density standard solution with 1000 milli osmotic pressure molar densities and 2000 milli osmotic pressure molar density standard solution
5.5 measure the osmotic pressure molar density of need testing solution again, should meet the requirement of product indicia amount.
5.6 the preparation of osmotic pressure molar density standard solution:
5.6.1 get benchmark sodium chloride reagent,, put to put in the silica gel drier and be chilled to room temperature in 500～600 ℃ of dryings 40～50 minutes; Take by weighing in right amount by " osmotic pressure molar density determinator is proofreaied and correct and used the standard solution table " institute's column data precision, be dissolved in the 100ml water, shake up, promptly get.
5.6.2 proofreading and correct, osmotic pressure molar density determinator uses the standard solution table
| Milli osmotic pressure molar density (mOsmol/kg) | The weight (g) of sodium chloride in every 100g water |
| 1000 | 3.201 |
| 2000 | 6.420 |
| 3000 | 9.638 |
7 potential of hydrogen: the pH value of Adlerika should be 5.5 ± 1 in the magnesium sulfate dressing sheet.
8 microbiological indicators:
8.1 total number of bacterial colonies (cfu/g or cfu/mL)≤200;
8.2 fungus colony sum (cfu/g or cfu/mL)≤100;
8.3 coliform does not detect;
8.4 pathogenic suppuration bacterium does not detect.
The good effect that the magnesium sulfate dressing tablet quality detection method that the present invention sets up is had is:
In the venous transfusion process because negligent supervision causes non-aggressive, corrosive medicine or solution to get into surrounding tissue causes and ooze out and exosmose; Causing local subcutaneous tissue and swelling pain occurs, generally is to give the patient with the Adlerika and the gauze of the variable concentrations for preparing, and enjoins gauze folding; Spread on the affected part to alleviate the degree of swelling after soaking with Adlerika; But, be easy to cause bacteria attack under the environment of cleaning sterile because the difference on the individual operations can not guarantee Adlerika, gauze and utensil are operated in use; Infect in the affected part of patient's swelling as a result, has more increased patient's misery.The patient carries Adlerika and gauze voluntarily in addition, and needs of patients notes on gauze, adding at any time medicine during use, keeps local moist and enough drug concentrations, has brought very big inconvenience to the patient.In clinical use preparation also is to confirm that rule of thumb concentration 25% is 1/4th; 33% is 1/3rd; 50% i.e. 1/2nd clinical for ease use convenient configuration just do not have the technology quality index and the method for inspection.If the industrialization of magnesium sulfate dressing sheet production standard just should be formulated the quality of the method for quality inspection in order to the control product.
The present invention is that the moistening degree in the magnesium sulfate dressing sheet is controlled in 0.07g ± 0.02 with every square centimeter of Adlerika amount of extruding; Calculate MgSO by the product indicia amount
47H
2Magnesium sulphate content should be 25-50 % ± 7 and controls magnesium sulphate content in the O Adlerika; Should be 1.9-2.9 Osmol/kg with osmotic pressure molar density mensuration, control product osmotic pressure molar density.Quality determining method of the present invention not only can carry out qualitative detection, can also carry out detection by quantitative, has represented the pharmacologically active of magnesium sulfate dressing sheet, can not only characterize its inherent quality effectively, is more suitable for effective control of product quality in production run.
More effective to the quality control of magnesium sulfate dressing sheet finished product through experiment showed, quality determining method of the present invention, method precision, stability, repeatability are all higher.Can effectively control the quality of product, guarantee the stable and consistent of product quality, thereby guarantee that safety of products is effective.
Particularly with the magnesium sulfate dressing sheet syringe of packing into; The extruding of push injection device; Get the Adlerika extruded as the method for answering the quantitative determination of sulfur acid magnesium solution in every square centimeter of magnesium sulfate dressing sheet; The not only practical but also effective Adlerika amount of monitoring product at any time in process of production, and easy and simple to handle, and control is effectively.
Embodiment
In order to explain enforcement of the present invention more fully, the embodiment of following assay method is provided.These embodiments only are to explain rather than limit scope of the present invention.Through typical embodiment the present invention is done further explanation below.
Embodiment 1
Specification is that 6 * 9cm magnesium sulphate content is the quality testing of 33% ± 7 magnesium sulfate dressing sheet:
(1) product structure, composition and material: every magnesium sulfate dressing sheet is made up of Adlerika and nonwoven fabrics, and Adlerika is by MgSO
47H
2O and purified water are made into.
(2) outward appearance: this magnesium sulfate dressing sheet is clean and tidy on inspection, defectives such as no brownish red or light-yellow precipitate, broken hole, stain, mildew, impurity.
(3) size: this magnesium sulfate dressing sheet is 5 on inspection, and every wide 6cm * long 9cm does not all surpass ± 10%.
(4) differentiate:
1. supply producing of examination solution, get 8-10 of magnesium sulfate dressing sheets as test sample, with the magnesium sulfate dressing sheet syringe of packing into, the extruding of push injection device is got the Adlerika extruded as supplying examination solution;
2. get the 50mL Adlerika of extruding by 1 and try solution as confession.
3. sulfate: get and supply examination solution, drip the barium chloride test solution, promptly generate white precipitate, separate, be deposited in hydrochloric acid or the nitric acid and all do not dissolve.
4. magnesium salts: get and supply examination solution, hydro-oxidation sodium test solution promptly generates white precipitate, separates, and deposition is divided into two parts, adds excessive sodium hydroxide test solution in the portion, precipitates insoluble; Another part adds iodine test solution, and deposition changes into rufous.
(5) supply producing of examination solution, get 5 of magnesium sulfate dressing sheets as test sample, respectively with the magnesium sulfate dressing sheet syringe of packing into, the extruding of push injection device is got the Adlerika extruded as supplying examination solution; Carry out weighing respectively.
Area is 6 * 9cm=54 cm
2The magnesium sulfate dressing sheet calculate the Adlerika amount and should be 2.70g-4.86g;
| Inspection article numbering | Inspection article weight g | Whether up to specification (scope 2.70g-4.86g) |
| 1 | 3.86 g | Up to specification |
| 2 | 3.90 g | Up to specification |
| 3 | 3.96 g | Up to specification |
| 4 | 3.90 g | Up to specification |
| 5 | 3.98 g | Up to specification |
(6) the magnesium sulphate assay in the Adlerika in the magnesium sulfate dressing sheet is got the magnesium sulfate dressing sheet as test sample, gets the Adlerika of extruding and tries solution as supplying, and gets 1mL and supplies examination solution, puts in the 25mL measuring bottle; Test sample 10cm with the Adlerika of extruding
2, put in the beaker, add water 5ml, soaked 15 minutes and stirring constantly, soak solution is transferred in the 25ml measuring bottle, water 5ml washing is 3 times respectively, merges cleansing solution to the 25ml measuring bottle, and thin up shakes up to scale, is dilution; Precision is measured dilution 10mL ammonification-ammonium chloride buffer (pH10.0) 10mL, chromium black T indicator a little, with Calcium Disodium Versenate vs (0.05mol/L) titration, change pure blue into by aubergine to solution, promptly get; Every 1mL Calcium Disodium Versenate vs (0.05mol/L) is equivalent to the MgSO of 12.32mg
47H
2O is 0.35% to meet 33% ± 7 requirement of product indicia amount through calculating magnesium sulphate content.
(7) potential of hydrogen: the pH value of Adlerika should be 5.5 ± 1 in the magnesium sulfate dressing sheet.
1. by the preparation method who supplies examination solution, produce 50mL and supply examination solution;
2. use the Starter 3C of Ao Haosi (Shanghai) Co., Ltd. type pH meter, precision is that 0.1 pH meter is measured as: 5.7 is up to specification.
(8) osmotic pressure molar density is measured and should be 1.9 ± 0.7Osmol/kg
1. by the preparation method who supplies examination solution, produce 50mL and supply examination solution; Instrument: the STY-1 of Tianda Tianfa Science and Technology Co. Ltd. type osmotic tester;
2. getting 8-10mL newly boils and puts cold water and rectify an instrument zero point;
3. rectify an instrument respectively with 1000 milli osmotic pressure molar densities and 2000 milli osmotic pressure molar density standard solution then;
4. the osmotic pressure molar density of measuring need testing solution is: 1.78 Osmol/kg, and up to specification.
Claims (1)
1. the quality determining method of a magnesium sulfate dressing sheet comprises: the step that discriminating, assay, potential of hydrogen mensuration, microbiological indicator mensuration, assay, osmotic pressure molar density are measured is characterized in that:
(1) assay is undertaken by following step:
1) get 1 of test sample, measure its area, with the magnesium sulfate dressing sheet syringe of packing into, the extruding of push injection device, answering the sulfur acid magnesium solution in every square centimeter of magnesium sulfate dressing sheet is 0.07g ± 0.02;
2) the magnesium sulphate content of Adlerika should be 25-50% ± 7 in the magnesium sulfate dressing sheet; Its method:
Get the magnesium sulfate dressing sheet as test sample, get the Adlerika of extruding and try solution, get 1mL and supply examination solution, put in the 25mL measuring bottle as supplying; Test sample 10cm with the Adlerika of extruding
2, put in the beaker, add water 5ml, soaked 15 minutes and stirring constantly, soak solution is transferred in the 25ml measuring bottle, water 5ml washing is 3 times respectively, merges cleansing solution to the 25ml measuring bottle, and thin up shakes up to scale, is dilution; Precision is measured dilution 10mL ammonification-ammonium chloride buffer, pH10.010mL, chromium black T indicator a little, with the titration of 0.05mol/L Calcium Disodium Versenate vs, change pure blue into by aubergine to solution, promptly get; Every 1mL Calcium Disodium Versenate vs is equivalent to the MgSO of 12.32mg
47H
2O is through calculating the requirement that should meet the product indicia amount;
(2) osmotic pressure molar density is measured and is undertaken by following step:
Get that to extrude Adlerika an amount of as supplying examination solution, getting newly boils in right amount puts cold water and rectifies an instrument zero point, selects two kinds of standard solution to rectify an instrument then, measures the osmotic pressure molar density of need testing solution again, should be 1.9-2.9 ± 0.7 Osmol/kg;
(3) preparation of osmotic pressure molar density standard solution:
1. get benchmark sodium chloride reagent,, put to put in the silica gel drier and be chilled to room temperature in 500～600 ℃ of dryings 40～50 minutes; Take by weighing in right amount by " osmotic pressure molar density determinator is proofreaied and correct and used the standard solution table " institute's column data precision, be dissolved in the 100ml water, shake up, promptly get;
2. osmotic pressure molar density determinator is proofreaied and correct and is used the standard solution table
。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210142552.7A CN102636618B (en) | 2012-05-10 | 2012-05-10 | Method for quality inspection of magnesium sulfate wet dressing sheet |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210142552.7A CN102636618B (en) | 2012-05-10 | 2012-05-10 | Method for quality inspection of magnesium sulfate wet dressing sheet |
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| CN102636618A true CN102636618A (en) | 2012-08-15 |
| CN102636618B CN102636618B (en) | 2014-09-17 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112415157A (en) * | 2020-11-24 | 2021-02-26 | 内蒙古祈蒙药业股份有限公司 | Quality control method of Anxiao six-ingredient granules |
-
2012
- 2012-05-10 CN CN201210142552.7A patent/CN102636618B/en not_active Expired - Fee Related
Non-Patent Citations (2)
| Title |
|---|
| 何欣: "渗透压摩尔浓度测定仪校准方法的研究", 《计量技术》 * |
| 李宇 等: "容量法测定硫酸镁注射液含量的不确定度评定", 《光谱实验室》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112415157A (en) * | 2020-11-24 | 2021-02-26 | 内蒙古祈蒙药业股份有限公司 | Quality control method of Anxiao six-ingredient granules |
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| CN102636618B (en) | 2014-09-17 |
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